Core Temperature Variations During Midazolam vs Propofol Sedation for Neuraxial Anesthesia

Hospital da Luz, Portugal

Status: Completed

Conditions: Body Temperature Changes; Anesthesia

Treatments: Device: SpotOn; Drug: Midazolam; Drug: Standard; Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT02502877

HDLSpot1

Details and patient eligibility

About

The present study is a pilot study aiming to compare the variation in core temperature (measured through the non-invasive device Spot-OnTM3MTM) in patients submitted to neuraxial anesthesia for orthopedic procedures, during sedation with midazolam vs propofol.

Full description

In this study the investigators will select 20 patients scheduled for orthopedic surgery of the knee or foot with neuraxial anesthesia (subarachnoid or sequential blocks). Sedation for these procedures with midazolam or propofol is daily practice in the investigators' department.

So the patients will be randomized, through the envelope method, in 2 groups with 10 patients each: "midazolam group" and "propofol group".

In the "midazolam group" the investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.

In the "propofol group" the investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol target-controlled infusion (TCI) pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.

The neuraxial block will be performed inside the operating room and preferentially in lateral decubitus. The choice of drug and dosage used for the block will be left to the anesthesiologist, to mimetize day-to-day practice. The limit dermatome of sensory block will be noted.

The investigators will administer to every patient: cefazolin 2g iv bolus, ketorolac 30 mg iv bolus, pantoprazole 40 mg iv bolus, paracetamol 1g iv perfusion (initiated 30 minutes before the end of surgery).

Central temperature will be monitored with the SpotOnTM3MTM device from entering till leaving the operating room, through a sensor placed in the patient's forehead. Room temperature will be kept at 17 degrees Celsius (ºC). Patients will be warmed with a underbody forced-air blanket (BairHuggerTM3MTM) set at 38ºC and maximal flow, initiated after performing the neuraxial block and stopped right before leaving the operating room.

Data will be analyzed with the Statistical Package for the Social Sciences (SPSS) program.

Enrollment: 27 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled for orthopedic surgery of the foot or knee
• Indication to neuraxial anesthesia
• Surgery duration > 30 minutes

Exclusion criteria

• Preference for deep sedation
• Preference for no sedation
• Kidney failure
• Hepatic failure
• No signed informed consent

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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27 participants in 2 patient groups

Midazolam Group

Other group

Description:

In the "midazolam group" the investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.

Treatment:

Drug: Midazolam

Drug: Standard

Device: SpotOn

Propofol group

Active Comparator group

Description:

In the "propofol group" the investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol TCI pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.

Treatment:

Drug: Propofol

Drug: Standard

Device: SpotOn